VOLTAROL PAIN-EZE TABLETS

Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER
Voltarol® Joint Pain
12.5 mg Tablets
Diclofenac potassium
Read all of this leaflet carefully before you start taking Voltarol Joint Pain 12.5 mg
Tablets.
It contains important information for you. Follow the instructions below to get the best
results.
• Keep this leaflet, you may need to read it again
• Ask a doctor or a pharmacist if you need more information or advice
• Contact a doctor if your symptoms worsen or do not improve within 3 days
• If any of the side effects get serious or if you notice any side effect not listed in this leaflet,
please tell your doctor or pharmacist
In this leaflet
1. What Voltarol Joint Pain 12.5 mg Tablets are and what they are used for
2. Before you take Voltarol Joint Pain 12.5 mg Tablets
3. How to take Voltarol Joint Pain 12.5 mg Tablets
4. Possible side effects
5. How to store Voltarol Joint Pain 12.5 mg Tablets
6. Further information
1. What Voltarol Joint Pain 12.5 mg Tablets are and what they are used for
Voltarol Joint Pain 12.5 mg Tablets contain diclofenac which belongs to a group of
medicines called “non-steroidal anti-inflammatory drugs” (NSAIDs). This medicine is a pain
reliever which also reduces inflammation (swelling) and fever.
Voltarol Joint Pain 12.5 mg Tablets provide relief from:
• muscular pain, joint (rheumatic) pain, backache, headache, dental pain, period pain.
• symptoms of colds and flu. This medicine also reduces fever.
2. Before you take Voltarol Joint Pain 12.5 mg Tablets
Do not take Voltarol Joint Pain 12.5 mg Tablets if you:
• are allergic to diclofenac or to any of the other ingredients (listed at the end of this leaflet,
section 6)
• have ever had an allergic reaction to medicines used to treat pain, inflammation or fever,
such as diclofenac, ibuprofen or aspirin (a substance also used to prevent blood clotting).
Reactions may include: asthma, wheezing, skin rash, face swelling, runny nose. If you are not
sure, ask your doctor or pharmacist
• currently have or have ever had a stomach or intestinal ulcer, bleeding or perforation which
may show up as a severe indigestion
• have noticed blood in your stools or black stools or vomiting blood or your vomit looks like
coffee granules (symptoms of gastrointestinal bleeding)
• suffer from severe kidney or liver disease
• suffer from severe heart failure
• are breast feeding

• are in the last 3 months of pregnancy
If any of these apply to you, consult your doctor and do not take these tablets.
Take special care and ask a doctor or pharmacist before use if you:
• have had stomach discomfort or heartburn after taking pain relievers or anti-inflammatory
medicines in the past
• have or have had asthma, diabetes, high cholesterol, high blood pressure, swollen feet, a
stroke, liver, heart, kidney or bowel problems.
• are intolerant to some sugars
• are on a controlled potassium diet
• are a smoker
• have a bleeding disorder or other blood disorders, including a rare liver condition called
hepatic porphyria
• are at risk of being dehydrated (e.g. by sickness, diarrhoea, or before or after major surgery)
If any of these apply to you, tell your doctor or pharmacist before you take these tablets.
Other precautions
• Medicines such as diclofenac may be associated with a small increased risk of heart attack
(myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged
treatment. Do not exceed the recommended dose or duration of treatment.
• Voltarol Joint Pain 12.5 mg Tablets may reduce the symptoms of an infection (e.g.
headache, high temperature) and may therefore make it more difficult to detect. If you feel
unwell and need to see a doctor, remember to tell them that you are taking Voltarol Joint Pain
12.5 mg Tablets.
• Prolonged use of any type of painkiller for headaches can make them worse. If you think
that this may be the case, please contact your doctor for advice.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including any you have bought without a prescription.
• Lithium or a class of antidepressant drugs called SSRIs such as fluoxetine or paroxetine (to
treat depression)
• Digoxin (a medicine used for heart problems)
• ACE inhibitors or beta-blockers (for high blood pressure and heart failure)
• Methotrexate (to treat some kinds of cancer or arthritis)
• Medicines used to treat diabetes, except insulin
• Diuretics (to increase the amount of urine)
• Medicines used to prevent blood-clotting (“blood thinners” or anticoagulants)
• Other anti-inflammatory medicines or pain killers such as aspirin, ibuprofen or naproxen
(includes cyclooxygenase-2 selective inhibitors (COX2) like celecoxib).
• Corticosteroids (for relief of inflamed areas of the body)
• Ciclosporin, tacrolimus (immunosuppressant for patients who have received organ
transplants)
• Some medicines used against infection (quinolone antibacterials).
• Sulfinpyrazone (a medicine used to treat gout) or voriconazole (a medicine used to treat
fungal infections)
• Pheytoin (a medicine used to treat seizures)
• Colestipol and chlestyramine (medicines used to regulate cholesterol)

Taking Voltarol Joint Pain Tablets with food and drink
Take the tablets with or after food.
Elderly
As with other pain relievers, elderly people may be more sensitive to the effects of Voltarol
Joint Pain 12.5 mg Tablets than other adults. Follow the instructions carefully and take the
lowest number of tablets that provides relief of symptoms. It is especially important for
elderly patients to report undesirable effects promptly to their doctor.
Children
Do not give Voltarol Joint Pain 12.5 mg Tablets to children under 14 years of age.
Pregnancy
If you are pregnant or think that you may be pregnant, tell your doctor and do not take
Voltarol Joint Pain 12.5 mg Tablets. It is especially important not to take Voltarol Joint Pain
Tablets during the last 3 months of pregnancy, as it could harm your unborn child or cause
problems at delivery. As with other anti-inflammatory medicines, the use of diclofenac, the
active substance in Voltarol Joint Pain 12.5 mg Tablets, may make it more difficult to
become pregnant. This is reversible on stopping the medicine. You should inform your doctor
if you are planning to become pregnant or if you have problems becoming pregnant.
Breast-feeding
Do not take Voltarol Joint Pain 12.5 mg Tablets if you are breast-feeding as it might be
harmful for your infant. Tell your doctor if you are breast-feeding.
Driving and using machines
Usually this medicine has no influence on the ability to drive or use machines. However, in
rare cases, you may experience vision disorders, dizziness or drowsiness. If you notice such
effects, do not drive or use machines. Tell your doctor as soon as possible.
Important information about some of the ingredients
Voltarol Joint Pain 12.5 mg Tablets contain lactose. If you have been told by your doctor that
you have an intolerance to some sugars, ask your doctor before taking this medicine.
3. How to take Voltarol Joint Pain 12.5 mg Tablets
For adults and children aged 14 years and over
It is important that you use the lowest dose that controls your pain and that you do not take
Voltarol Joint Pain 12.5 mg Tablets for longer than necessary.
Take an initial dose of 2 tablets when symptoms appear. If needed, continue with 1 or 2
tablets every 4 to 6 hours. Do not take more than 6 tablets per day. Do not take Voltarol Joint
Pain 12.5 mg Tablets for more than 3 days.
Swallow the tablets whole with a drink of water.
If you forget to take Voltarol Joint Pain 12.5 mg Tablets
If you miss a dose, take the next dose as soon as you remember. If it is nearly time for your
next dose, take the next tablet at the usual time. Do not take a double dose to make up for a
forgotten tablet.

Do not take too much
If symptoms persist or worsen, tell your doctor to ensure that they are not due to a serious
illness. Do not take more than the recommended dose.
If you take more Voltarol Joint Pain 12.5 mg Tablets than you should
If you have taken too many tablets, tell your doctor or pharmacist or go to the hospital
emergency unit at once. You may require medical attention. If possible, take the medicine
with you.
4. Possible side effects
Like all medicines Voltarol Joint Pain Tablets can sometimes cause side effects, although not
everybody gets them.
If you experience any of the side-effects, STOP taking Voltarol Joint Pain Tablets
IMMEDIATELY and seek medical advice. These including the following:
• Swelling of the face and throat.
• Drowsiness.
• Rash.
• Blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome).
• Blood disorders including reduction in blood platelets, which increases the risk of bleeding
or bruising (Thrombocytopenia).
• Gastrointestinal bleeding, severe stomach pain, bloody or black stool, vomiting blood,
stomach and intestine ulcer. These may be sign and symptoms of ulceration, bleeding and
perforation of the stomach or intestines.
• Constipation.
• Taste disorders.
• Tingling or numbness of the hands or feet, trembling.
• Blurred vision, double vision, ringing in the ears, impaired hearing palpitations.
• Change in moods, difficulty sleeping, feeling confused.
Some rare or very rare serious side effects
These side effects may affect up to between 1 and 10 in every 10,000 people.
• severe stomach pain, blood in the stool or black stool, vomiting blood.
• Allergic reaction including swelling of the face, mouth, tongue or throat, often associated
with skin rash. Collapse.
• Wheezing and feelings of tightness in the chest (signs of asthma).
• Chest pain (signs of heart attack), fainting, high blood pressure.
• Sudden and severe headache, stiff neck, difficulty to speak, convulsions.
• Skin rash with blisters, peeling of the skin, purple skin lesions, blistering of the mouth or
eyes.
• Swelling of arms, hands, legs and feet (oedema).
• Any change in the appearance or amount of urine.
• Yellowing of the skins or eyes (signs of hepatitis/liver failure).
• Unusual bleeding or bruising, high fever or persistent sore throat.
Medicines such as diclofenac may be associated with a small increased risk of heart attack
(also called ‘myocardial infarction’) or stroke.
If you experience any of these, STOP taking Voltarol Joint Pain Tablets and tell a doctor
straight away.

Other side effects
Other side effects which may occur are usually mild. Some of the effects have been reported
with higher doses of diclofenac, the active substance in Voltarol Joint Pain Tablets, used for
longer duration. If you find these are troubling you, talk to a doctor or pharmacist.
Some side effects are common
These side effects may affect between 1 and 10 in every 100 people.
• Pain in the gut, stomach pain, diarrhoea, nausea, vomiting, flatulence.
• Headache, dizziness.
• Skin rash.
Some side effects are rare
These side effects may affect between 1 and 10 in every 10,000 people.
• Drowsiness.
Some side effects are very rare
These side effects may affect less than 1 in every 10,000 people.
• Constipation, mouth sores, taste disorders.
• Tingling or numbness of the hands or feet, trembling.
• Blurred vision, ringing in the ears, palpitations.
• Change in mood, difficulty sleeping, feeling confused.
If any of the side effects get serious or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
5. How to store Voltarol Joint Pain 12.5 mg Tablets
• Keep out of the reach and sight of children.
• Do not store above 25°C.
• Do not take the tablets after the expiry date which is stated on the carton after EXP
(abbreviation used for expiry date). The expiry date refers to the last day of that month.
• Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.
6. Further information
What Voltarol Joint Pain 12.5 mg Tablets contain
• The active substance is diclofenac potassium. Each tablet contains 12.5 mg of diclofenac
potassium.
• The other ingredients are: silica, lactose, maize starch, sodium starch glycolate, polyvidone,
magnesium stearate, microcrystalline cellulose, hypromellose, titanium dioxide (E171)
macrogol, polysorbate and maltodextrin.
What Voltarol Joint Pain 12.5 mg Tablets look like and contents of the pack
Voltarol Joint Pain 12.5 mg Tablets are small, white, film-coated tablets, available in packs of
18 tablets.
Marketing Authorisation Holder
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road,
Brentford, TW8 9GS, U.K.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.